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South Dakota Legislature passes significant bioscience bill

Feb 13, 2018

South Dakota Legislature passes significant bioscience bill

With a unanimous vote in the House and Senate, South Dakota became the latest state to endorse a biologics substitution law.

The laws establish consistent standards for when a biosimilar prescription product can replace an original biologic product.

South Dakota’s Legislature was the first this year to pass the law. With Gov. Dennis Daugaard’s signature, South Dakota became the 37th state to pass such a law.

“This is such important public policy, and it was gratifying to see our lawmakers so significantly endorse it,” said Joni Johnson, executive director of South Dakota Biotech.

Traditionally, similar statutes have allowed for substitution of generic prescriptions for brand-name counterparts. Biologics are more complex and include injectable treatments for arthritis; medicines for cancer, diabetes, Crohn’s disease and psoriasis; the Hepatitis B vaccine; and pending stem cell therapies.

“This is really about patient safety and pharmacists being able to safely substitute interchangeable biologics, and equally importantly it’s about cost savings to patients,” said Greg Hoke, director of state government affairs for BIO. “It’s one of the real, tangible reasons we anticipate health care costs can come down.”

South Dakota’s law is consistent with recommendations from the international BIO organization:

Substitution should occur only when the FDA has designated a biologic product “interchangeable.”

The prescribing physician should be able to prevent substitution.

The prescribing physician should be notified of the substitution.

The patient should be notified of the substitution.

The pharmacist and the physician should keep records of the substitution.

While there is no interchangeable biologic on the market yet, the FDA has established guidelines for manufacturers so they can begin working through the process.

“What has been seen in countries where they are available is costs have come down,” Hoke said. “Once legislators understand how important this is to patients and providers and they see that manufacturers as well as physicians and pharmacists and pharmacy groups are on the same page, it becomes a much easier sell.”

Johnson agreed.

“This approach is a win-win for all involved – for our patients, our medical professionals and our scientists pioneering new treatments,” Johnson said. “We thank the state for showing such leadership on this issue.”

Advocacy efforts in South Dakota were led by lobbyists Drew Duncan and Justin Smith and representatives of Amgen and Genentech.

“The folks in South Dakota did a masterful job,” Hoke said. “They were phenomenal.”